Anxiety, Colonoscopy, Colorectal Neoplasms, Mass Screening, Quality of Life
Conditions
Keywords
Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety
Brief summary
Colorectal cancer screening program has been proven to reduce colorectal cancer (CRC) mortality and is cost-effective. It has been adopted by most countries in the world, and colonoscopy is regarded as the most accurate test for detecting colorectal neoplasm. After screenees underwent colonoscopy, most endoscopists do not routinely explain the preliminary optical diagnosis to the subjects before they going home, which may cause unnecessary anxiety and may reduce the quality of life of the subjects before acquiring the final results. In recent years, endoscopic optical diagnostic technology has been validated by meta-analysis studies as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer. The real time feature of endoscopic optical diagnosis allows endoscopists to explain the preliminary results confidently to the subjects immediately after colonoscopy, which is expected to reduce the anxiety of the subjects before they acquired the final results and improve their quality of life. We designed a randomized controlled trial to validate whether real-time endoscopic optical diagnosis could decrease the anxiety burden and improve the quality of life for colorectal-cancer screenees after colonoscopy.
Interventions
OTHERReal-time colonoscopic optical diagnosis for colorectal neoplasm
Colonoscopic optical diagnosis by image enhanced technology has been validated as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer.
Sponsors
Fu Jen Catholic University Hospital
Fu Jen Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who preparing to received screening or surveillance colonoscopy under general anesthesia. * Patients who preparing to received sedated colonoscopy due to other GI tract related symptoms.
Exclusion criteria
* Impaired mental status that could not understand the questionnaire questions. * Patients with major psychological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life degree | 2 weeks | Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depression degree | 2 weeks | Use Hospital Anxiety and Depression Scale (HADS) Taiwanese version to measure the anxiety and depression degree between the two study arms. |
Countries
Taiwan
Contacts
Primary ContactChen-Ya Kuo, MD
Outcome results
None listed